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Celltracks Analyzer Ii

FDA UDI

Class II (US FDA UDI)

by Menarini Silicon Biosystems Inc.

Identity

Trade Name
CELLTRACKS ANALYZER II FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
Device Name
CELLTRACKS ANALYZER II - EU ROHS Compliant FDA UDI
Model / Reference
9555 FDA UDI
Description
CELLTRACKS ANALYZER II - EU ROHS Compliant FDA UDI

Identifiers

Catalog Number
9555 FDA UDI
Primary DI / UDI-DI
10888385000658 FDA UDI
510(k) Number
K130794 FDA UDI
FDA Product Code
NQI FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Celltracks Analyzer Ii by Menarini Silicon Biosystems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Menarini Silicon Biosystems Inc.

Sources (1)

  • FDA UDI b7568472-396c-45e5-89a1-4d6dcd6106df 37 fields · synced May 31, 2026